BioCentury
ARTICLE | Clinical News

Ceftolozane/tazobactam: Additional Phase III data

September 1, 2014 7:00 AM UTC

Additional pooled data from 1,083 patients with cUTI in a pair of identical, double-blind, international Phase III trials showed that 1.5 g IV ceftolozane/tazobactam every 8 hours for 7 days led to a composite cure rate consisting of microbiological eradication and clinical cure in the mMITT population at the TOC visit 5-9 days after the end of therapy, the FDA-defined primary endpoint, of 76.9% vs. 68.4% for IV levofloxacin. Ceftolozane/tazobactam led to a microbiological eradication rate in the mMITT population, the EMA-defined primary endpoint, of 80.4% vs. 72.1% for levofloxacin. Data were presented at the European Congress of Clinical Microbiology and Infectious Diseases in Barcelona. Cubist previously reported that ceftolozane/tazobactam met the FDA- and EMA-defined primary endpoints of non-inferiority to levofloxacin (see BioCentury, Dec. 9, 2013). ...